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FDA 510(k)

FACSMATE SAMPLE HANDLING DEVICE

K-Number: K885132 · 1988-12-28

ApplicantBd Becton Dickinson Vacutainer Systems Preanalytic
Decision Date1988-12-28
Product CodeGKL
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

FACSMATE SAMPLE HANDLING DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Bd Becton Dickinson Vacutainer Systems Preanalytic. It received FDA 510(k) clearance on 1988-12-28 under 510(k) number K885132. The device is classified under product code GKL. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FACSMATE SAMPLE HANDLING DEVICE?

FACSMATE SAMPLE HANDLING DEVICE is a medical device that received FDA 510(k) clearance on 1988-12-28. The listed applicant is Bd Becton Dickinson Vacutainer Systems Preanalytic. The 510(k) number is K885132.

When did FACSMATE SAMPLE HANDLING DEVICE receive FDA 510(k) clearance?

FACSMATE SAMPLE HANDLING DEVICE received FDA 510(k) clearance on 1988-12-28, under 510(k) number K885132.

Who is the listed applicant for FACSMATE SAMPLE HANDLING DEVICE?

The FDA 510(k) record lists Bd Becton Dickinson Vacutainer Systems Preanalytic as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FACSMATE SAMPLE HANDLING DEVICE?

The FDA product code for FACSMATE SAMPLE HANDLING DEVICE is GKL.

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Related Devices (Code: GKL)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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